BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2211440 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03307
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATION BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED DISTAL STENT DAMAGE. STRUTS ON FIRST THREE ROWS FROM THE DISTAL END WERE RAISED AND MISALIGNED. THE OUTER DIAMETER (OD) OF THE STENT DAMAGE WAS MEASURED USING A SNAP GAUGE AND WAS APPROXIMATELY 1.81MM. THE OD OF THE STENT AREA WHERE NO DAMAGE WAS PRESENT WAS MEASURED AT APPROXIMATELY 1.13MM. NO ISSUES WERE NOTED WITH THE CRIMPED STENT, THE BALLOON AND TIP SECTIONS OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE STENT FAILED TO CROSS THE LESION. THE VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PRE-DILATED. A 28X3.50MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS SELECTED. WHILE ADVANCING THE SDS RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL STENT DAMAGE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 0013277475

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR